A Prospective, Non-interventional, Multinational, Observational Study With Isatuximab in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)
A Prospective, Non-interventional, Multinational, Observational Study With Isatuximab in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)
Primary Objective:
To assess the effectiveness, in terms of overall response rate (ORR) of isatuximab patients with RRMM in routine clinical practice, within 12 months
To assess other effectiveness parameters such as progression free survival (PFS), PFS rate (PFSR), duration of response (DoR), time to response, time and intent to first subsequent therapy, rate of very good partial response or better, rate of complete response (CR) or better of isatuximab patients with RRMM in routine clinical practice
To assess the profile of patients (demographic, disease characteristics, comorbidities and prior MM treatment history) who are treated with isatuximab in routine clinical practice
To describe safety of isatuximab in routine clinical practice (based on adverse event [AE] reporting)
To assess quality of life (QoL) using the European Organization for Research and Treatment of Cancer (EORTC) 30 item core questionnaire (QLQ C30) and the accompanying 20 item myeloma questionnaire module (QLQ MY20)
Secondary Objective:
Not applicable
Duration per participant is 2.5 years
Most important exclusion criteria for potential participants:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. Further eligibility criteria might apply.
Little Rock, Arkansas 72205-7199, United States
San Francisco, California 94143, United States
Lakeland, Florida 33805, United States
Farmington Hills, Michigan 48334, United States
Freehold, New Jersey 07728, United States
Howell Township, New Jersey 07731, United States
Little Silver, New Jersey 07739, United States
Winston-Salem, North Carolina 27103, United States
Massillon, Ohio 44646, United States
Charleston, South Carolina 29414, United States
Greenville, South Carolina 29615, United States
Watertown, South Dakota 57201-1548, United States
Ciudad Autonoma Buenos Aires, Buenos Aires 1199, Argentina
Essey-lès-Nancy, 54270, France
Cologne, 50677, Germany
Dortmund, 44263, Germany
Frankfurt am Main, 60389, Germany
Kulmbach, 95326, Germany
Marburg, 35037, Germany
Rome, Roma 00133, Italy
Rome, Roma 00137, Italy
Bologna, 40138, Italy
Brescia, 25123, Italy
Naples, 80138, Italy
Sunto-gun, Shizuoka 411-8777, Japan
Minato-ku, Tokyo 105-8470, Japan
Osakasayama-shi, 589-8511, Japan
Shibukawa-shi, 377-0280, Japan
Suwa-shi, 392-8510, Japan
Hato Rey, 00917, Puerto Rico
Palma de Mallorca, Balearic Islands 07120, Spain
León, León 24071, Spain
Málaga, Málaga 29010, Spain
Pamplona, Navarre 31008, Spain
Granada, 18012, Spain
Pontevedra, 36001, Spain
San Cristóbal de La Laguna, 38320, Spain
Huddersfield, HD3 3EA, United Kingdom